Material Event Form 8 K

Item 8.01 Other Events

MIRA Pharmaceuticals Validates Ketamir-2's Safety Profile with No Adverse Findings, Paving the Way for IND Submission by Year-End

MIRA Pharmaceuticals, Inc. (the "Company"), a preclinical-stage pharmaceutical development company, announced the successful completion of its current Good Laboratory Practice (GLP) preclinical safety program for Ketamir-2, a novel oral ketamine analog. The results of these studies demonstrated no adverse findings, clearing a significant milestone toward the submission of the Company's Investigational New Drug (IND) application by the end of 2024.

The preclinical safety program included evaluations across cardiovascular, central nervous system (CNS), and respiratory systems, as well as toxicology studies. Key findings included:

The Company plans to initiate Phase I clinical trials for Ketamir-2 in the first quarter of 2025, focusing on its safety, tolerability, pharmacokinetics, and pharmacodynamics. This trial will incorporate pain evaluation metrics to assess Ketamir-2's potential in treating neuropathic pain and psychosis, with early data expected by the second quarter of 2025.

Cautionary Note Regarding Forward-Looking Statements

This press release and the statements of MIRA Pharmaceuticals' (or the "Company") management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the study results described herein as well as the timing for the Company's other preclinical studies and the filing of an IND for Ketamir-2. Any forward-looking statements in this press release are based on the Company's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2023, and other SEC filings, which are on file with the SEC at www.sec.govand the Company's website at https://www.mirapharmaceuticals.com/investors/sec-filings. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.